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United States · US · US:51655-331_48eb115f-7702-67c8-e063-6394a90a98a3

acetazolamide

Orange BookUNIISPLATC S01EC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNorthwind Health Company, LLC
CountryUS (United States)
ATC codeS01EC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5165533152
    30 TABLET in 1 BOTTLE, PLASTIC (51655-331-52)

Annotations

UNII (FDA Substance ID)
O3FX965V0I
ACETAZOLAMIDE
RxCUI 167
Orange Book
A205530
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "O3FX965V0I",
    "rxcui": "167",
    "inchikey": "BZKPWHYZMXOIDC-UHFFFAOYSA-N",
    "display_name": "ACETAZOLAMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c5acf531-ba55-47b7-88db-e5da0206ebf1": {
      "match": "brand_token",
      "title": "ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]",
      "spl_version": "5",
      "published_date": "2026-05-25"
    }
  },
  "productid": "51655-331_48eb115f-7702-67c8-e063-6394a90a98a3",
  "productndc": "51655-331",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205530",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG",
        "product_no": "001",
        "approval_date": "Oct 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Oct 27, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAZOLAMIDE",
  "proprietary_name": "acetazolamide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205530",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acetazolamide",
  "start_marketing_date": "20230328",
  "active_numerator_strength": "125"
}

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